Arista AH Absorbable Hemostat
FDA PMAClass III (US FDA PMA)
by Davol Inc.
Identity
- Trade Name
- ARISTA AH ABSORBABLE HEMOSTAT FDA PMA
- Generic Name
- Agent, absorbable hemostatic, non-collagen based FDA PMA
Identifiers
- PMA Number
- P050038 FDA PMA
- FDA Product Code
- LMG FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Legislation / Framework
- 21 CFR Part 878.4490 FDA PMA
- Regulation Number
- 878.4490 FDA PMA
- Advisory Committee
- General, Plastic Surgery FDA PMA
- FDA Decision
- APPR Approved FDA PMA
Arista AH is an absorbable hemostatic agent, non-collagen based, designed to assist in the control of bleeding during surgical procedures. It is indicated for use when conventional methods such as pressure or ligature are ineffective or impractical for managing capillary, venous, and arteriolar bleeding.
This device is intended for use in general and plastic surgery, excluding neurological, ophthalmic, and urological procedures. It has received FDA PMA authorization for clinical use. Please consult the product labeling for specific storage and handling requirements.
Frequently asked questions
What is the primary use of Arista AH?
Arista AH is used as an adjunctive hemostatic device to help control bleeding in capillary, venous, and arteriolar vessels when standard procedures like pressure or ligation are not sufficient.
Are there any surgical restrictions for this device?
Yes, Arista AH is not indicated for use in neurological, ophthalmic, or urological surgical procedures.
Is Arista AH a collagen-based product?
No, Arista AH is classified as a non-collagen based absorbable hemostatic agent.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P050038 | Class III | Active |
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Manufacturer
- Manufacturer
- Davol Inc.
- FDA Applicant
- Davol, Inc.
Sources (1)
- FDA PMA P050038 24 fields · synced Sep 18, 2026